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FDA 510(k)

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

N.º K: K193325 · 2020-03-13

SolicitanteProsys International, Ltd.
Fecha de decisión2020-03-13
Código de productoKNT
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Prosys International, Ltd.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193325. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Prosys International, Ltd.. The 510(k) number is K193325.

When did Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches receive FDA 510(k) clearance?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193325.

Who is the listed applicant for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

The FDA 510(k) record lists Prosys International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

The FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is KNT.

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Dispositivos relacionados (Código: KNT)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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